Tenodesis implants and tools

ABSTRACT

Methods and devices are provided for anchoring a ligament or tendon to bone. In one embodiment, a biceps tenodesis system is provided and includes a sheath inserter tool, an expandable sheath configured to couple to the sheath inserter tool, an expander inserter tool, and an expander configured to couple to the expander inserter tool. The sheath inserter tool is configured to advance the expandable sheath, with a tendon disposed therearound, into a bone hole, and the expander inserter tool is configured to advance the expander through an outer shaft of the sheath inserter tool and to drive the expander into the sheath. The expander is configured to be received within a lumen extending at least partially through the expandable sheath to thereby expand the sheath. In this way, the system delivers the tendon or ligament into the bone hole and locks the sheath and tendon within the bone hole.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No.15/093,938, filed on Apr. 8, 2016, and entitled “Tenodesis Implants andTools,” which is hereby incorporated by reference in its entirety.

FIELD

Surgical devices and methods are provided for anchoring tissue to bone,and more particularly surgical implants, delivery tools, and methods areprovided for securing a biceps tendon to the humerus.

BACKGROUND

Disorders of the long head of the biceps tendon are a common source ofshoulder pain and may occur in association with other diagnoses such asrotator cuff tears, superior labrum anterior posterior tears,impingement syndrome and capsular injuries, or may be present as anisolated source of shoulder pain. The treatment options for disorders ofthe long head of the biceps (LHB) continue to evolve and can include LHBtenodesis. In a tenodesis procedure, a suture is passed through the baseof the LHB to locate the LHB in the subacromial space and to provideproximal control during the dissection. Once the suture is placed, theLHB is cut near the glenoid attachment. A sizer can be used to measurethe tendon size and to thereby determine the appropriately sized bonescrew. Once the screw is selected, a bone hole is drilled and a tendonfork is then used to push the tendon down into the bone hole. A bonescrew is then delivered into the bone hole to anchor the tendon withinthe bone hole.

While current procedures can provide an effective means for anchoring atendon to bone, they can suffer from several drawbacks. For example,current procedures require the use of numerous tools, which can lead toa prolonged procedure and increased costs. The use of a screw can alsoincrease the risk of damage to the tendon, as rotation of the screw intothe bone hole can tear or sever through the tendon. Moreover, it can bedifficult to maintain the desired tension on the tendon while the screwis being implanted, as the tendon can become misaligned and or can slipduring insertion of the screw. Any tension applied to the tendon duringinsertion of the anchor can also cause the anchor to back-out of thebone hole.

Accordingly, there remains a need for improved methods and devices foranchoring tissue to bone, and in particular for performing a bicepstenodesis.

SUMMARY

Various implants, tools and methods are provided for attaching a tendonto bone. In one embodiment, an anchor assembly is provided and includesa sheath having a first sidewall with proximal and distal ends and asecond sidewall with proximal and distal ends. The distal ends of thefirst and second sidewalls can be coupled to one another by a hinge pinsuch that the first and second sidewalls pivot relative to one anotherabout the hinge pin. The anchor assembly can also include an expanderhaving a generally elongate cylindrical configuration. The expander canbe configured to be received between the first and second sidewalls ofthe sheath to cause the first and second sidewalls to pivot about thehinge pin and move laterally away from one another.

While the sheath can have a variety of configurations, in one embodimenteach of the first and second sidewalls can have a substantiallyrectangular shape with a hemi-cylindrical cavity formed on one sidethereof for seating the expander. The sheath can include first andsecond tabs on the first and second sidewalls. The first and second tabscan be positioned at a substantial mid-portion of the first and secondsidewalls between the proximal and distal ends, and the first and secondtabs can be configured to receive a portion of a tool therebetween whenthe proximal ends of the first and second sidewalls are positionedadjacent to one another.

In other aspects, the proximal end of each of the first and secondsidewalls can include a boss formed thereon and configured to engagethreads on the expander to maintain alignment between the sheath and theexpander. The boss on each sidewall can extend toward the other one ofthe first and second sidewalls such that the proximal ends of the firstand second sidewalls substantially circumferentially surround theexpander.

In another embodiment, the first and second sidewalls can each have aninternal surface facing one another and an opposite external surface,and the external surface of each of the first and second sidewalls canhave ribs formed thereon. The ribs can extend substantiallyperpendicular to a longitudinal axis running extending in aproximal-distal direction. In an exemplary embodiment, an externalsurface of each of the first and second sidewalls has a plurality ofrows of ribs arranged in at least on column, each rib extendingsubstantially perpendicular to a longitudinal axis extending in aproximal-distal direction. At least one of the ribs in a proximal-mostrow of ribs can have a height that is greater than a height of the ribsin the rows distal of the proximal-most row.

In other aspects, each of the first and second sidewalls can have atleast one protrusion with a bore formed therein and having the hinge pinextending therethrough. For example, the distal end of the firstsidewall can have a first protrusion having a bore formed therein withthe hinge pin extending therethrough and a second protrusion having abore formed therein with the hinge pin extending therethrough, and thesecond sidewall can have a third protrusion having a bore formed thereinwith the hinge pin extending therethrough and a fourth protrusion havinga bore formed with the hinge pin extending therethrough. In certainaspects, the third protrusion can be positioned between the first andsecond protrusions, and the second protrusion can be positioned betweenthe third and fourth protrusions.

In another embodiment, at least one of the first and second sidewallscan include a proximal tab extending radially outward from the sidewallsuch that the tab is effective to limit an insertion depth of the sheathinto a bone hole.

At least one of the first and second sidewalls can include asuture-receiving tab formed thereon and defining a suture-receivingopening extending therethrough. In certain aspects, the suture-receivingtab can extend substantially perpendicular to a longitudinal axis of thesheath such that suture-receiving opening has a central axis thatextends substantially parallel to the longitudinal axis of the sheath.

In another embodiment, a bone anchor inserter tool is provided andincludes an elongate shaft having proximal and distal ends and an innerlumen extending therethrough. The distal end has first and second prongsextending distally therefrom and positioned on opposite sides of theshaft. Each prong has a first pair of bosses positioned adjacent aproximal end of each prong and a second pair of bosses positioned atadjacent a mid-portion of each prong. In one embodiment, the first pairof bosses can extend radially outward from each prong by a firstdistance and the second pair of bosses can extend radially outward fromeach prong by a second distance that is less than the first distance.Each prong can have a concave inner surface. The tool can also includeother features. For example, the elongate shaft can include at least oneviewing window formed in a sidewall thereof at a location proximal tothe first and second prongs to allow viewing into the inner lumen of theelongate shaft.

A tendon anchoring system is also provided and in one embodiment thesystem includes an anchor assembly having a sheath with first and secondsidewalls that are coupled at a distal end by a hinge pin such that thefirst and second sidewalls are configured to pivot about the hinge pinrelative to one another. Each sidewall can have an anti-rotation bossformed thereon. The system can also include an inserter tool having anelongate shaft with an inner lumen extending therethrough betweenproximal and distal ends. The distal end can have first and secondprongs extending distally therefrom from opposite sides thereof andconfigured to extend along opposed sides of the first and secondsidewalls of the sheath such that the first and second prongs areengaged between the anti-rotation boss on each sidewall to preventrotation of the sheath relative to the first and second prongs.

Each sidewall can include a retention boss positioned proximal of theanti-rotation boss and configured to engage an expander positionedbetween the first and second sidewalls of the anchor assembly. The firstand second prongs can each include a proximal boss positioned proximalof the retention boss on the first and second sidewalls, and a distalboss positioned proximal of the anti-rotation boss on the first andsecond sidewalls and distal of the retention boss on the first andsecond sidewalls.

The system can also include an expander having a generally elongatecylindrical configuration and configured to be received between thefirst and second sidewalls of the sheath to cause the first and secondsidewalls to pivot about the hinge pin and move laterally away from oneanother.

In other aspects, a proximal end of at least one of the first and secondsidewalls has a tab extending radially outward therefrom. The tab can bereceived within a slot in the distal end of the elongate shaft of theinserter tool to facilitate engagement between the sheath and theinserter tool.

In another embodiment, a bone anchoring system is provided and includesa sheath having a first sidewall with proximal and distal ends and asecond sidewall with proximal and distal ends. The distal ends of thefirst and second sidewalls are coupled to one another by a hinge pinsuch that the first and second sidewalls pivot relative to one anotherabout the hinge pin. The system also includes an elongate shaft having adistal end with a distally-extending central protrusion that extendsinto the sheath between the first and second sidewalls. The distal endhas at least first and second distally-extending side protrusionspositioned on opposite sides of the central protrusion and extendingalong opposite outer sides of the first and second sidewalls such thatthe first and second distally-extending side protrusions preventrotation of the first and second sidewalls about the hinge pin.

In one embodiment, the distally-extending central protrusion extends adistance beyond the first and second distally-extending sideprotrusions. In other aspects, the distally-extending central protrusionand the first and second distally-extending side protrusions define aradially extending slot therebetween that seats a proximal-most end ofthe first and second sidewalls. The distally-extending centralprotrusion can have an oblong cross-sectional shape such that thedistally-extending central protrusion is prevented from rotating withinthe first and second sidewalls.

The elongate shaft can also include third and fourth distally-extendingside protrusions positioned on opposite sides of the central protrusionand extending along opposite outer sides of the first and secondsidewalls. In certain aspects, the first and second outer sidewalls eachhave a plurality of teeth formed thereon, and the first and thirddistally-extending side protrusions are positioned on opposite sides ofa tooth formed on an outer surface of the first sidewall, and the secondand fourth distally-extending side protrusions are positioned onopposite sides of a tooth formed on an outer surface of the secondsidewall.

The elongate shaft can also include a handle slidably coupled to aproximal end of the elongate shaft. In one embodiment, the elongateshaft has proximal and distal components that are rotatably coupled toone another, and the proximal component is mated to a handle.

In yet another embodiment, a bone anchor inserter tool is provided andincludes an outer shaft having proximal and distal ends and an innerlumen extending at least partially therethrough. The distal end hasfirst and second prongs extending distally therefrom. The tool alsoincludes an inner shaft extending through the inner lumen of the outershaft. At least a portion of the inner shaft can be non-rotatably andfreely slidably coupled to the outer shaft, and the inner shaft can havea distal end with a distally-extending central protrusion and at leastfirst and second distally-extending side protrusions positioned onopposite sides of the central protrusion.

In one embodiment, the inner shaft can include a distal component thatis non-rotatable relative to the outer shaft, and a proximal componentthat is rotatably coupled to the distal component. The proximal anddistal components of the inner shaft can be mated by a snap-fitconnection. The tool can also include a handle coupled to the proximalend of the outer shaft and coupled to the proximal component of theinner shaft. In other aspects, the inner shaft can include third andfourth distally-extending side protrusions positioned on opposite sidesof the central protrusion.

A tendon anchoring system is also provided and in one embodiment thesystem includes an anchor assembly having a sheath with first and secondsidewalls that are coupled at a distal end by a hinge pin such that thefirst and second sidewalls are configured to pivot about the hinge pinrelative to one another. The system also includes an inserter toolhaving an outer shaft with an inner lumen extending therethrough betweenproximal and distal ends thereof. The distal end can have first andsecond prongs extending distally therefrom. The inserter tool alsoincludes an inner shaft extending through the inner lumen of the outershaft and having a distal end configured to engage the first and secondsidewalls of the sheath to prevent pivotal movement of the first andsecond sidewalls about the hinge pin.

The anchor assembly can also include an expander configured to bereceived within the sheath to cause the first and second sidewalls topivot away from one another. In one embodiment, the first and secondsidewalls each have at least one retention boss formed thereon andconfigured to engage a proximal end of the expander when the expander isseated between the first and second sidewalls. In other aspects, theexpander can have an inner lumen extending therethrough with a cross-barextending across the inner lumen for receiving a suture therearound.

The sidewalls can have a variety of configurations. The first and secondsidewalls can each include at least one anti-rotation boss formedthereon and configured to engage at least one of the first and secondprongs therebetween to prevent rotation of the sheath relative to theouter shaft. In other aspects, the first and second prongs can includeproximal slots formed therein that receive tabs formed on the proximalends of the first and second sidewalls of the sheath. The tabs can beconfigured to slide out of the slots when the first and second sidewallsof the sheath pivotally move away from one another.

Surgical methods are also provided, and in one embodiment the method caninclude advancing a sheath into a bone hole, and advancing an expanderinto the sheath, the expander causing first and second sidewalls of thesheath to pivot relative to one another about a hinge pin couplingdistal ends of the first and second sidewalls. Advancing the sheath caninclude, for example, manipulating an inserter tool having the sheathmounted on a distal end thereof to advance the sheath into a bone hole.In one aspect, the inserter tool can have first and second prongs thatextend between the first and second sidewalls of the sheath, and thefirst and second prongs can include anti-rotation bosses thereon thatprevent rotation of the sheath relative to the first and second prongsduring advancement of the sheath into the bone hole. In another aspect,the inserter tool can include an outer shaft and an inner shaft. Theinner shaft can have a distally-extending central protrusion thatextends into the sheath between the first and second sidewalls, and atleast first and second distally-extending side protrusions positioned onopposite sides of the central protrusion and extending along oppositeouter sides of the first and second sidewalls such that the first andsecond distally-extending side protrusions prevent rotation of the firstand second sidewalls of the sheath about the hinge pin.

BRIEF DESCRIPTION OF THE DRAWINGS

The embodiments described above will be more fully understood from thefollowing detailed description taken in conjunction with theaccompanying drawings. The drawings are not intended to be drawn toscale. For purposes of clarity, not every component may be labeled inevery drawing. In the drawings:

FIG. 1 side perspective view of one embodiment of a biceps tenodesissystem that includes a sheath inserter tool having an expandable sheathcoupled thereto, and an expander inserter tool having an expandercoupled thereto;

FIG. 2A is a side perspective view of the sheath of FIG. 1;

FIG. 2B is an exploded side perspective view of the sheath of FIG. 2A;

FIG. 2C is a side view of the sheath of FIG. 2A;

FIG. 2D is another side view of the sheath of FIG. 2A;

FIG. 2E is a side perspective view another embodiment of a sheath foruse with a biceps tenodesis system;

FIG. 2F is a side perspective view of yet another embodiment of a sheathfor use with a biceps tenodesis system;

FIG. 3A is a side perspective view of the expander of FIG. 1;

FIG. 3B is a top perspective view of the expander of FIG. 1;

FIG. 4A is a perspective view of another embodiment of a sheath insertertool;

FIG. 4B is a side perspective view of a distal end of an outer shaft ofthe sheath inserter tool of FIG. 4A;

FIG. 4C is a side view of the distal end of the outer shaft of thesheath inserter tool of FIG. 4B coupled to the sheath of FIG. 1;

FIG. 4D is a side perspective view of a handle portion of the sheathinserter tool of FIG. 4A;

FIG. 4E is a side perspective view of a distal end of an inner shaft ofthe sheath inserter tool of FIG. 4A;

FIG. 4F is a side perspective view of the distal end of the inner shaftof FIG. 4E coupled to the sheath of FIG. 1;

FIG. 5A is a side, partially transparent view of the sheath insertertool of FIG. 4A having the sheath of FIG. 1 mounted thereon and havingthe expander of FIG. 1 mounted therein;

FIG. 5B is a side, partially transparent view of the assembly shown inFIG. 5A, with the expander being advanced into the sheath;

FIG. 6 is a top perspective view of the sheath of FIG. 1 having theexpander of FIG. 1 fully disposed therein;

FIG. 7 is a side perspective view of another embodiment of a sheathinserter tool and sheath for use with a biceps tenodesis system;

FIG. 8A is an exploded side perspective view of the sheath of FIG. 7;

FIG. 8B is a side perspective view of the sheath of FIG. 7;

FIG. 9A is an exploded side perspective view of the sheath inserter tooland sheath of FIG. 7;

FIG. 9B is a side perspective view of a distal end of the sheathinserter tool of FIG. 7;

FIG. 9C is a side perspective view of a handle portion of the sheathinserter tool of FIG. 7;

FIG. 9D is an end perspective view of a distal end of an inner shaft ofthe sheath inserter tool of FIG. 7; and

FIG. 10 is a side perspective view of a distal end of the sheathinserter tool of FIG. 7 with the sheath of FIG. 7 coupled thereto.

DETAILED DESCRIPTION

Certain exemplary embodiments will now be described to provide anoverall understanding of the principles of the structure, function,manufacture, and use of the devices and methods disclosed herein. One ormore examples of these embodiments are illustrated in the accompanyingdrawings. Those skilled in the art will understand that the devices andmethods specifically described herein and illustrated in theaccompanying drawings are non-limiting exemplary embodiments and thatthe scope of the present invention is defined solely by the claims. Thefeatures illustrated or described in connection with one exemplaryembodiment may be combined with the features of other embodiments. Suchmodifications and variations are intended to be included within thescope of the present invention.

Reference throughout the specification to “various embodiments,” “someembodiments,” “one embodiment,” or “an embodiment”, or the like, meansthat a particular feature, structure, or characteristic described inconnection with the embodiment is included in at least one embodiment.Thus, appearances of the phrases “in various embodiments,” “in someembodiments,” “in one embodiment,” or “in an embodiment”, or the like,in places throughout the specification are not necessarily all referringto the same embodiment. Furthermore, the particular features,structures, or characteristics may be combined in any suitable manner inone or more embodiments. Thus, the particular features, structures, orcharacteristics illustrated or described in connection with oneembodiment may be combined, in whole or in part, with the featuresstructures, or characteristics of one or more other embodiments withoutlimitation.

It will be appreciated that the terms “proximal” and “distal” may beused throughout the specification with reference to a clinicianmanipulating one end of an instrument used to treat a patient. The term“proximal” refers to the portion of the instrument closest to theclinician and the term “distal” refers to the portion located furthestfrom the clinician. It will be further appreciated that for concisenessand clarity, spatial terms such as “vertical,” “horizontal,” “up,” and“down” may be used herein with respect to the illustrated embodiments.However, surgical instruments may be used in many orientations andpositions, and these terms are not intended to be limiting and absolute.

In general, methods and devices are provided for anchoring a ligament ortendon to bone. In an exemplary embodiment, the methods and devices areused to perform a biceps tenodesis surgery, however, a person skilled inthe art will appreciate that the devices and methods can be used invarious procedures and for anchoring any tissue to bone. In exemplaryembodiments, various inserter tools are provided for delivering variousbone anchors including an expandable sheath and an expander into a bonehole to anchor a tendon or other issue within the bone hole. The sheathcan be anchored without rotating the sheath, which can eliminate orreduce a possibility of undesirable twisting of the tendon.

FIG. 1 illustrates one embodiment of a biceps tenodesis system 10 thatincludes a sheath inserter tool 100 having an expandable sheath 200coupled thereto, and an expander inserter tool 300 having an expander400 coupled thereto. The sheath inserter tool 100 has an outer shaft102, an inner shaft 104, and a handle 106 coupled to proximal ends ofthe outer and inner shafts 102, 104. The sheath inserter tool 100 isconfigured to advance the expandable sheath 200, with a tendon disposedtherearound, into a bone hole, and the expander inserter tool 300 isconfigured to advance the expander 400 through the outer shaft 102 ofthe sheath inserter tool 100 and to drive the expander 400 into thesheath 200. The expander 400 is configured to be received within a lumenextending at least partially through the expandable sheath 200 tothereby expand the sheath 200. In this way, the system 10 delivers thetendon or ligament into the bone hole and locks the sheath 200 andtendon within the bone hole. A person skilled in the art will appreciatethat each of the components of the system 10 can have a variety ofconfigurations and thus various expandable sheaths, expanders, sheathinserter tools, and expander inserter tools are disclosed herein, eachof which can be used interchangeably with any of the other componentsdisclosed herein.

FIGS. 2A-2D illustrate the sheath 200 of FIG. 1 in more detail. Ingeneral, the sheath is configured to seat a tendon therearound, and toreceive the expander 400 therein, which is effective to cause the sheathto expand into bone to anchor the tendon within a bone hole. The sheathcan be formed from any bio-compatible material, and, in someembodiments, it can be bio-absorbable. The shape and configuration ofthe sheath can vary. By way of example, the sheath 200 can be configuredas described at least in U.S. patent application Ser. No. 14/610,602,entitled “Biceps Tenodesis Implants and Delivery Tools,” filed Jan. 30,2015, and in U.S. patent application Ser. No. 14/693,276, entitled“Biceps Repair Device,” the contents of which are incorporated herein byreference in their entireties.

In general, the sheath 200 has an elongate substantially rectangularshape, with a length extending between a proximal end 200 p and a distalend 200 d that is greater than a width extending between opposing sides.The sheath 200 is configured to move from a collapsed position to anexpanded position in which the sheath has more of a cylindricalconfiguration for conforming to the cylindrical shape of a bone hole. Inthis embodiment, the sheath 200 is a split sheath, with first and secondseparate and distinct sidewalls 202, 204 that are connected at thedistal end 200 d. Each sidewall 202, 204 can have a substantiallyrectangular shape with an outer bone engaging surface and an innersurface configured to mate with the expander 400. The sidewalls 202, 204can define an inner lumen 206 therebetween as well as slots 200 a, 200 bextending along opposite sides thereof adjacent to the edges of eachsidewall 202, 204.

In the illustrated embodiment, the outer surface of each sidewall 202,204 has a substantially convex shape with a plurality of bone engagingsurface features formed thereon. While the surface features can have avariety of shapes and sizes, in the illustrated embodiment the surfacefeatures are in the form of ribs or teeth 208 that are aligned incolumns between the proximal and distal ends 200 p, 200 d as well as inrows between the opposed sides. In particular, the illustrated sidewalls202, 204 each have three columns of teeth arranged in five rows. Aperson skilled in the art will appreciate that each sidewall 202, 204can include any numbers of rows and columns of teeth, such as two ormore columns and any number of rows which can vary based on the lengthof the sidewall. While each row can include a single elongate rib,providing multiple ribs in a single row (and thus providing multiplecolumns) can increase the flexibility of the sidewall 202, 204, allowingeach sidewall to more readily deform against an inner surface of a bonehole. Moreover, the one or more longitudinal gaps formed between eachcolumn can help prevent damage to the tendon. The space in between thecolumns can provide an area for the tendon to deform into, thuspreventing the tendon from being entirely pinched by the ribs.

Each tooth can have a variety of configurations. In the illustratedembodiment, each tooth is generally rectangular with four sides and atop surface that is substantially planar. The teeth 208 can all havesubstantially the same height such that the top surfaces all reside inthe same plane. However, in one embodiment one or more of theproximal-most teeth can differ from the remainder of the teeth. Forexample, the proximal-most central tooth 208 c can have a height that isgreater than the height of the remainder of the teeth. Such aconfiguration can facilitate engagement with the bone hole to preventsheath back-out. Such a configuration can also help preventintra-operative or post-operative push-in of the implant further intothe bone hole, especially where a modicum of cancellous bone exists. Oneor more of the teeth nearest the proximal end can also include ridgesformed on the top surface thereof to further facilitate engagement withbone. For example, each tooth in the top row of teeth, including centraltooth 208 c, is shown having three ridges formed thereon. A personskilled in the art will appreciate that the teeth can have a variety ofconfigurations and that in other embodiments the sidewalls 202, 204 canhave threads or any other bone engaging surface features formed thereon.

The inner surface of each sidewall 202, 204 can also have a variety ofconfigurations, but it is preferably configured to receive the expander400 therein. In the illustrated embodiment, the inner surface of eachsidewall 202, 204 has a substantially concave configuration with threads210 formed therein for mating with corresponding threads formed on theexpander 400. In this way, when the expander 400 is threaded into thesheath 200, the expander 400 will engage the threads 210 in the sheath200 to prevent the expander 400 from backing out of the sheath 200.

As indicated above, the first and second sidewalls 202, 204 areconnected at their distal ends. In the illustrated embodiment, thesidewalls 202, 204 are connected by a hinge such that the sidewalls 202,204 are pivotably movable relative to one another. As a result, thesidewalls 202, 204 can be moved away from one another at the proximalend 200 p of the sheath 200 when the expander 400 is received therein.The hinged connection at the distal end 200 d of the sheath 200 can beachieved using a variety of techniques. As shown in FIG. 2B, the distalend of each sidewall 202, 204 has a bore 202 bg, 204 b formed thereinand extending across the sidewall 202, 204. The distal end of eachsidewall 202, 204 also includes gaps or cutout regions 202 c, 204 cformed therein and offset from the other sidewall 202, 204 such thateach sidewall 202, 204 has two cylindrical protrusions 212 a, 212 b, 214a, 214 b, each having a bore formed therethrough. The two cylindricalprotrusions 212 a, 212 b on one sidewall 202 are received between thetwo cylindrical protrusions 214 a, 214 b on the other sidewall 204 so asto align all of the bores 202 b, 204 b and form a single bore, as shownin FIG. 2D, for receiving a single hinge pin 220 therethrough.

The hinge pin 220, also shown in FIG. 2B, is in the form of a generallyelongate cylindrical member having a head 222 at one end and opposedspring arms 226 a, 226 b at the opposite end. The spring arms 226 a, 226b are formed by a cutout 224 extending partially into the end of thehinge pin 220. Each spring arm 226 a, 226 b includes a flange 228 a, 228b formed around an external surface thereof. In use, the hinge pin 220can be passed through the bore 202 b, 204 b formed in the protrusions atthe distal end of the sidewalls 202, 204. The spring arms 226 a, 226 bwill deflect inward while being passed through the bore, and once theflange 228 a, 228 b on each spring arm 226 a, 226 b exits the oppositeside of the bore, the spring arms 226 a, 226 b will deflect outwardreturning to their resting position in which the flange 228 a, 228 b oneach spring arm 226 a, 226 b will engage the end surface of protrusion212 a on sidewall 202 (or protrusion 214 b on sidewall 204) so as toprevent removal of the hinge pin 220 from the sidewalls 202, 204. Thehinge pin 220 is thus fixed within the bore and is not removable. Thesidewalls 202, 204 are free to pivot about the hinge pin 220.

The sheath 200 can also include other features formed thereon or thereinto facilitate engagement with the bone, the expander 400, or the varioustools used therewith. For example, in one embodiment the sidewalls caneach include one or more tabs extending outward from opposite sidesthereof to engage the prongs on the inserter tool therebetween andthereby prevent rotation of the sheath relative to the tool, which willbe discussed in more detail below. As shown in FIG. 2C, each sidewall202, 204 of the sheath 200 includes left and right proximal or uppertabs 216 a, 216 b, 216 c, 216 d (only tabs 216 a, 216 b are shown inFIG. 2C) extending radially outward from opposite sides of a proximalend 200 p of the sheath 200, as well as left and right distal or lowertabs 218 a, 218 b, 218 c, 218 d (only tabs 218 a, 218 b are shown inFIG. 2C) extending radially outward from opposite sides of a mid- ordistal-portion of each sidewall 202, 204. Each of the illustrated tabshas a substantially rectangular configuration, however the tabs can havea variety of shapes and sizes.

The proximal or upper tabs 216 a, 216 b, 216 c, 216 d and the distal orlower tabs 218 a, 218 b, 218 c, 218 d can function as anti-rotationtabs. For example, the prongs of the inserter tool 100 (discussed below)can extend between the tabs on sidewall 202 and the tabs on sidewall 204such that the tabs engage the prongs therebetween. As a result, theentire sheath 200 is prevented from rotating about an axis that extendsbetween the sidewalls 202, 204 and perpendicular to the longitudinalaxis of the sheath.

The upper tabs 216 a, 216 b, 216 c, 216 d and the lower tabs 218 a, 218b, 218 c, 218 d can also maintain the position of the sheath 200 on thedistal end of the sheath inserter tool 100. As will be discussed in moredetail below, since a feature on the prongs extends between the upperand lower tabs 216 a-d, 218 a-d on the sheath 200, the position of thesheath 200 with respect to the prongs on the sheath inserter tool 100 isfixed.

The upper tabs 216 a, 216 b, 216 c, 216 d can also be used to advancethe sheath into a bone hole, or to maintain the sheath within the bonehole during insertion of the expander into the sheath. For example, withparticularly thick tendon, the tendon may apply a proximal force to thesheath. It may be desirable to apply a distal force to the tool, whichin turn acts on the upper tabs, to hold the sheath in place or toadvance the sheath into the bone hole.

As best shown in FIGS. 2B and 2D, each sidewall 202, 204 can alsoinclude a retention boss 219 a, 219 b formed on at least one side of theproximal end thereof. Each retention boss 219 a, 219 b can be in theform of a protrusion extending circumferentially from the terminal endof the sidewall 202, 204 such that the protrusion forms an extension ofthe proximal-most thread on each sidewall 202, 204. Each retention boss219 a, 219 b will thus extend partially around the expander 400 tocircumferentially engage the expander to maintain contact with theexpander once the sheath 200 and expander 400 are implanted. Such aconfiguration can reduce the risk of expander dislodgmentpost-operatively. As shown in FIGS. 2B and 2C, in order to accommodatethe retention boss (only 219 b is shown), one of the side teeth in theproximal-most row of teeth can include a notch or cut-out 208 s formedtherein for allowing the retention boss to extend therethrough.

A person skilled in the art will appreciate that the sheath 200 canadditionally or alternatively include any other suitable features. Forexample, the sheath 200 can include anti-collapse tabs or depth-stoptabs, discussed in more detail in U.S. patent application Ser. No.14/610,602.

By way of non-limiting example, FIG. 2E illustrates sheath 200′, whichis similar to sheath 200 but that includes depth-stop tabs 221 a′, 221b′ formed thereon adjacent to the retention bosses 219 a′, 219 b′. Thedepth-stop tabs 221 a′, 221 b′ extend outward from the sheath on opposedsides thereof such that they extend beyond the largest width of eachsidewall of the sheath. As a result, when the sheath is inserted into abone hole having substantially the same diameter as the sheath, thedepth-stop tabs 221 a′, 221 b′ will abut against a proximal surface ofthe bone to prevent further insertion of the sheath into the bone hole.Such a configuration can be particularly advantageous with certain typesof bone wherein it is desired to prevent the sheath from falling intothe bone hole. For example, the use of a sheath having depth-stop tabs221 a′, 221 b′ can be particularly advantageous in sub-pectorallocations since visibility can be particularly difficult.

FIG. 2F illustrates another embodiment of a sheath 200″ which is alsosimilar to sheath 200, but that includes a suture-receiving tab 203″formed thereon. As shown, the tab 203″ is in the form of a u-shapedmember that extends across one of the sidewalls, e.g., sidewall 202″,and that is located along a mid-portion of the sidewall 202″ adjacent toa distal end 200 d″ of the sidewall 202″. While only one tab 203″ isshown on one of the sidewalls 202″, a person skilled in the art willappreciate that the other sidewall, e.g., sidewall 204″, may or may nothave a suture-receiving tab 203″ formed thereon. As a result of theorientation of the tab 203″, the opening 205″ of the tab will extend ina proximal-distal direction so as to allow a suture coupled to a tendonlocated distal of the sheath 200″ to be advanced through the tab 203″from the distal end toward the proximal end. The trailing ends of thesuture extending proximally from the tab 203″ can be used to tension thetendon to pull the tendon toward the sheath 200″. The trailing ends ofthe suture can also be wrapped around a portion of the sheath insertertool, as discussed below, to maintain the sheath 200″ on the distal endof the inserter tool. A person skilled in the art will appreciate thatthe suture-receiving tabs 203″ can have a variety of shapes and sizes,and that various other suture-receiving features can be formed on thesheath at various locations.

As indicated above, the sheath 200 is configured to receive an expanderthat is effective to expand the sheath 200 to anchor the sheath 200 andtendon coupled thereto within a bone hole. As shown in FIGS. 3A and 3B,in one embodiment, the expander 400 is in the form of a threaded memberor screw having a generally cylindrical shape that tapers distallyinward to a reduced diameter along at least a distal portion of thelength thereof. Preferably, the taper is minor along a majority of thelength so that the expander 400 causes slow expansion of the sheath asit is inserted therein. The expander 400 has a thread 402 formed on theouter surface thereof and extending along the entire length of theexpander 400 to facilitate engagement with the sheath 200.

The expander 400 can be fully cannulated so that it has a bore or innerlumen 404 therein. The inner lumen 404, or at least a proximal portionthereof, can have a shape and size corresponding to a shape and size ofa drive feature configured to be received within the inner lumen 404 soas to rotate the expander 400. In the illustrated embodiment, the innerlumen 404 is in the form of a hexagonal drive socket configured toreceive a hexagonal distal portion of the expander inserter tool,discussed below. The hexagonal distal portion of the expander insertertool can be inserted into the inner lumen 404 as to extend along asubstantial portion of the entire length of the lumen 404. A personskilled in the art will appreciate, however, that other configurationsof the inner lumen 404 can be used.

As further shown in FIGS. 3A and 3B, the expander 400 can have a flatproximal facing surface 406 and a flat distal facing surface 408. Theproximal surface 406 and the distal surface 408, however, can havevarious shapes and the shape can be configured to conform to the sheathand/or the bone surface. A length of the expander 400 can be less than,equal to, or greater than the length of the sheath 200.

The expander 400 can also include features to allow for receipt of asuture. For example, as shown in FIG. 3B, the expander 400 includes asuture receiving bar or post-410 extending thereacross for receiving asuture there around. The post can be located anywhere along the lengthof the expander 400 between the proximal and distal ends thereof, and itcan extend at any angle. In the illustrated embodiment, the post 410extends substantially perpendicular to a longitudinal axis of theexpander 400.

A person skilled in the art will appreciate that the expander can have avariety of other configurations, and the expander can be configured tobe non-rotatably inserted into the sheath, rotatably inserted into thesheath, or partially non-rotatably and partially rotatably inserted intothe sheath. For example, the expander can include a proximal portionhaving threads formed thereon and a distal portion that is non-threadedand free of surface features. In use, the non-threaded distal portion ofthe expander can be non-rotatably advanced into the sheath. Once thedistal portion is fully disposed within the sheath, the expander canthen be rotated to thread the proximal portion into the sheath. Thesheath can include corresponding threads along an entire inner surfacethereof, or along on a proximal portion of the inner surface thereof,for mating with the threads on the expander.

As indicated above, the sheath 200 can be delivered into a bone holeusing the sheath inserter tool 100. The sheath inserter tool 100 isshown in more detail in FIG. 4A, and as shown the tool generallyincludes a cannulated outer shaft 102, an inner shaft 104 that extendsthrough the outer shaft 102, and a cannulated handle 106 that is matedto both the outer and inner shaft 102, 104. The outer shaft 102 has aproximal end 102 p that fixedly mates to the handle 106 and a distal end102 d having first and second prongs 108 a, 108 b extending distallytherefrom. In the illustrated embodiment, the proximal end 102 pincludes threads 110 formed thereon that threadably engage correspondingthreads 106 t (shown in FIG. 4D) formed within the handle 106 to fixedlymate the outer shaft 102 to the handle 106. Various other matingtechniques can be used, such as a snap-fit or other mechanicalinterlock. The inner shaft 104 also has a proximal end 104 p thatfixedly mates to the handle 106, but that is freely rotatable relativeto the handle 106 to allow the handle 106 to rotate and threadablyengage the outer shaft 102.

The handle can have a variety of configurations, but in the illustratedembodiment it has a generally elongate cylindrical shape with an innerlumen extending therethrough. A proximal end of the handle can begenerally planar for allowing a mallet to be applied thereto foradvancing the anchor coupled to the tool into a bone hole. The outersurface of the handle can have any shape and size to facilitategrasping. As indicated above, an inner lumen of the handle can beconfigured to receive the proximal ends of the outer and inner shafts102, 104. The configuration of the inner lumen will be discussed indetail below.

The handle can include features for mating a suture to the handle 106.In the illustrated embodiment, the handle includes opposed wings 106 a,106 b that have a suture receiving channel 106 s formed therearound(shown in FIG. 4D) for receiving a suture coupled to the implant. Thus,when an implant is being inserted through tissue and into a bone hole,the trailing ends of the suture coupled to the implant can be tensionedand wrapped around one of the wings 106 a, 106 b. In another embodiment,one or more suture receiving elements can be located on the outer shaft,rather than on the handle. Such a configuration allows the handle andthe inner shaft to be removed, leaving the outer shaft with the sutureand sheath coupled thereto.

Referring back to FIG. 4A, the outer shaft 102 can have a variety ofconfigurations. The illustrated proximal end 102 p of the outer shaft102 is shown having a knurled or other textured surface 112 tofacilitate grasping thereof. FIG. 4A also illustrates a window 114formed in a sidewall of the outer shaft 102 to enable viewing of theinner shaft 104 disposed therein. The window 114 can be formed at anylocation along the length of the outer shaft 102, and the outer shaft102 can include any number of windows formed therein. As indicatedabove, the proximal end 102 p of the outer shaft 102 includes threads110 formed on an outer surface thereof for engaging correspondingthreads 106 t formed within a distal portion of the inner lumenextending through the handle 106, as shown in FIG. 4D. The threadedengagement allows the handle 106, with the inner shaft 104 coupledthereto, to be advanced distally during threaded engagement with theouter shaft 102, thereby advancing a distal end of the inner shaft 104into engagement with the sheath, as will be discussed in more detailbelow. Threading of the handle 106 onto the outer shaft 102 will alsoalign the distal end of the inner shaft 104 with the sheath 200 and theouter shaft 102, as will also be discussed in more detail below.

The distal end 102 d of the outer shaft 102 is shown in more detail inFIG. 4B, and as shown the distal end 102 d tapers inward in the distaldirection and has opposed U-shaped cutouts 103 a, 103 b formed thereinsuch that the distal end 102 d includes first and second opposed arms orprongs 108 a, 108 b extend distally therefrom and configured to extendalong the opposed slots in the sheath 200.

While the prongs 108 a, 108 b can have a variety of configurations andfeatures, in the illustrated embodiment each prong 108 a, 108 b is inthe form of elongate pin or rod that is integrally formed with the outershaft 102 or fixedly attached to the outer shaft 102. Each prong 108 a,108 b is shown having a proximal portion with a width that tapers inwardand then flares outward to form a pair of proximal boss 114 a, 114 b,114 c, 114 d. Each prong 108 a, 108 b also has a distal portion having agenerally elongate shape with a substantially square or rectangularcross-section and a substantially constant diameter with a rounded ortapered distal tip. The proximal bosses 114 a, 114 b, 114 c, 114 d onthe prongs 118 a, 118 b can abut against the proximal or upper tabs 216a, 216 b, 216 c, 216 d on the sheath 200 to prevent proximal movement ofthe sheath when mated to the sheath inserter tool 100. A pair of distalbosses 116 a, 116 b, 116 c, 116 d is formed at a location distal of theproximal bosses 114 a, 114 b, 114 c, 114 d around a mid-portion of eachprong 118 a, 118 b. Each of the bosses 116 a, 116 b, 116 c, 116 d is inthe form of a protrusion extending outward from opposite sides of theprong 108 a, 108 b.

When the sheath 200 is mated to the sheath inserter tool 100, as shownin FIG. 4C, the upper and central tabs 216 a, 218 a on the firstsidewall 202 and the upper and central tabs 216 c, 218 c on the secondsidewall 204 will engage the second prong 108 b therebetween, and whilenot shown the upper and central tab 216 b, 218 b on the first sidewall202 and the upper and central tabs 216 d, 218 d on the second sidewall204 will engage the first prong 108 a therebetween. Due to the elongategenerally rectangular configuration of the tabs and the prongs beingengaged therebetween, the sheath 200 is prevented from rotating as aunit relative to the sheath inserter tool 100.

As further shown in FIG. 4C, the upper tab 216 a on the first sidewall202 will be seated between proximal boss 114 c and distal boss 116 c onthe second prong 108 b, and upper tab 216 c on the second sidewall 204will be seated between proximal boss 114 d and distal boss 116 d on thesecond prong 108 b. While not shown, upper tab 216 b on the firstsidewall 202 will be seated between proximal boss 114 a and distal boss116 a on the first prong 108 a, and upper tab 216 d on the secondsidewall 204 will be seated between proximal boss 114 b and distal boss116 b on first prong 108 a. As a result, the sheath 200 is preventedfrom moving proximally relative to the prongs 108 a, 108 b.

As further shown in FIG. 4C, when the sheath 200 is mated to the sheathinserter tool 100, the prongs 108 a, 108 b will extend a distance beyondthe distal end of the sheath 200. Such a configuration allows a tendonto be wrapped around the distal end of the sheath 200 and receivedbetween the prongs 108 a, 108 b, and it allows the prongs 108 a, 108 bto guide the sheath 200 into a bone hole.

Referring back to FIG. 4A, the inner shaft 104 of the sheath insertertool 100 can also have a variety of configurations, but is generally inthe form of an elongate shaft having a proximal end 104 p that is matedto the handle 106, and a distal end 104 d that mates to the sheath 200.The proximal end 104 p can mate to the handle 106 using a variety oftechniques, but in an exemplary embodiment the proximal end 104 p isfixedly, but freely rotatably mated to the handle 106. In theillustrated embodiment, the proximal end 104 p of the inner shaft 104includes a slot formed therein that defines two deflectable arms orfingers 105 a, 105 b. Each arm or finger 105 a, 105 b has a flange 107a, 107 b on the proximal-most end thereof. The handle 106 is configuredmate to the proximal end 104 p of the inner shaft 104 using a snap-fitarrangement. As shown in FIG. 4D, the inner lumen extending through thehandle 106 has a portion located proximal of the threads 106 t thatincludes a proximal section 120 p with a large diameter and amid-section 120 d with a reduced diameter, such that a step 122 isformed therebetween. The diameter of mid-section 120 d is configured toreceive the inner shaft 104 and to cause the fingers 105 a, 105 b on theproximal end of the inner shaft 104 to deflect inward when passedtherethrough. Once the flanges 107 a, 107 b extend proximally past thestep 122, the fingers 105 a, 105 b are allowed to deflect outward backto their resting position, in which the flanges 107 a, 107 b will engagethe step 122 to prevent removal of the inner shaft 104 from the handle106. The step 122 will also prevent distal movement of the inner shaft104 relative to the handle 106. The handle 106 will remain free torotate relative to the inner shaft 104, thus allowing the handle 106 tobe threaded onto the outer shaft 102 with the inner shaft 104 coupledthereto.

The inner shaft 104 can also include alignment features formed thereonfor aligning the inner shaft with the outer shaft 102, thereby aligningthe distal end 104 d of the inner shaft 104 with the sheath 200 coupledto the outer shaft 102. As shown in FIG. 4A, the inner shaft 104includes opposed elongate protrusions (only one protrusion 109 is shown)formed on opposed sides of a proximal end thereof. The outer shaft 102includes corresponding cut-outs or slots (only one slot 111 is shown)formed in opposite sides thereof for slidably receiving the protrusions109 therein.

The distal end of the inner shaft 104 is shown in more detail in FIG.4E, and as shown the distal end has a reduced diameter portion 124 andan increased diameter portion in the form of a radial flange 126 havinga circular shape. The diameter of the flange 126 can be substantiallythe same as the diameter of the sheath 200, and the flange 126 can havea substantially planer distal-facing end surface that abuts up againstthe proximal end of the sheath 200. The end surface can include one ormore protrusions formed thereon for mating with the sheath. As shown inFIG. 3E, the end surface includes a central protrusion 128 that isconfigured to be received between the sidewalls of the sheath 200. Thecentral protrusion 128 can thus have a size and shape that generallymatches the size and shape of the inner lumen of the sheath 200. In theillustrated embodiment, the central protrusion 128 has a generallyoblong cross-sectional shape. The non-circular geometry can beadvantageous as it will prevent rotation of the inner shaft 104 relativeto the sheath 200.

The end surface of the inner shaft 104 can also include one or moreprotrusions formed adjacent an outer perimeter thereof and configured toextend along an outer surface of each sidewall of the sheath. As shownin FIG. 3E, the end surface includes four protrusions 130 a-d formedthereon, with two protrusions 130 a, 130 b being positioned on a firstside to extend along an outer surface of the first sidewall 202 of thesheath 200, and the other two protrusions 130 c, 130 d being positionedon a second, opposite side to extend along an outer surface of thesecond sidewall 204 of the sheath 200. The four protrusions 130 a-d havea length and diameter that is significantly less than a length of thecentral protrusion 128, as the central protrusion is intended to occupya substantial portion of the inner lumen of the sheath 200. The fourprotrusions 130 a-d can also vary in shape, but in an exemplaryembodiment each protrusion has a generally rectangular or squarecross-sectional shape and is configured to extend between teeth in theproximal-most row of teeth on the sidewalls of the sheath 200. Inparticular, as shown in FIG. 4F, two of the protrusions 130 a, 130 blocated on one side of the inner shaft 104 will extend between theproximal-most central tooth 208 c and an outer tooth 208. Suchpositioning of the protrusions 130 a, 130 b between the teeth canfurther assist in preventing rotation of the inner shaft 104 relative tothe sheath 200.

Referring back to FIG. 1, when the system 10 is assembled, the sheath200 is positioned at the distal end 102 d of the outer shaft 102 suchthat the first and second prongs 108 a, 108 b extend along the elongateslots 200 a, 200 b in the sheath 200 and extend beyond the distal end200 d of the sheath 200. The central protrusion 128 on the inner shaft104 will extend into the central lumen of the sheath 200, and the outerprotrusions 130 a-d on the inner shaft 104 will extend around the outersidewalls of the sheath 200. The upper and lower tabs 216 a-d, 218 a-don the sheath 200 will engage the prongs 108 a, 108 b so as to preventrotation of the sheath 200 about an axis extending laterally across amid-portion of the sheath 200. The upper tabs 216 a-d on the sheath 200will be engaged between the proximal and distal bosses 116 a-d on theprongs 108 a, 108 b.

With continued reference to FIG. 1, as indicated above the system canalso include an expander inserter tool 300 for inserting the expander400 through the sheath inserter tool 100 and into the sheath 200. In anexemplary embodiment, as shown in FIG. 1, the expander inserter tool 300is in the form of a screw driver having a drive tip configured to extendinto the expander 400. In particular, the expander inserter tool 300 hasa handle 302 and an elongate shaft 304 extending distally from thehandle 302. The distal end of the elongate shaft 304 includes a drivetip 306 formed thereon for engaging the lumen 404 in the expander 400.In the illustrated embodiment, the drive tip 306 has a hexagonalconfiguration for extending into a corresponding hexagonal drive socket(shown in FIG. 3B) formed in the expander 400 to thereby allow theexpander inserter tool 300 to rotate the expander 400. However, oneskilled in the art will appreciate that the drive tip 306 can have anyother configuration so as to fit within the inner lumen of the expander400 and rotatably engage the expander 400.

When assembled, the expander inserter tool 300 extends through the outershaft 102 of the sheath inserter tool 100 (with the inner shaft 104being removed). The expander inserter tool 300 can rotate freelyrelative to the outer shaft 102 so as to thread the expander 400 intothe sheath 200. FIGS. 5A and 5B illustrate the expander inserter tool300 positioned within the outer shaft 102 of the sheath inserter tool100 and about to advance the expander 400 into the sheath 200. As theexpander 400 is introduced into the sheath 200, the retention boss (onlyone boss 219 a is shown) will engage the threads on the expander 400.Such a configuration can reduce the likelihood for intra- orpost-operative disengagement between the sheath and the expander. Sincethe diameter of the expander 400 is greater than an inner diameter ofthe sheath 200 in the collapsed position, the expander 400 will causethe sidewalls 202, 204 of the sheath 200 to pivot about the pivot pinand thereby expand outward to into bone. The assembly will thus engagethe bone thereby anchoring the tendon within the bone hole. FIG. 6illustrates a proximal end view of the sheath and expander in the fullyimplanted configuration.

FIGS. 7-10 illustrate another embodiment of a biceps tenodesis system 20that includes a sheath inserter tool 500 having an expandable sheath 600coupled thereto. The system 20 can be used with the expander insertertool and expander described above, and thus these components are notdiscussed with respect to this embodiment. In this embodiment, thesheath 600 has two separate and distinct halves that are not mated, butrather that have cross-bars that are held together by the sheathinserter tool 500 and that receive a tendon therearound. The sheathinserter tool 500 can include various feature for mating with andinteracting with the sheath.

The sheath 600 is shown in more detail in FIGS. 8A-8B and as shown, thesheath 600 has first and second sidewalls 602, 604 that are configuredto couple, but not mechanically mate, to one another. Each sidewall 602,604 has a substantially hemi-cylindrical shape with an inner concavesurface 602 i, 604 i configured to seat the expander, and an outerconvex surface with bone-engaging surface features formed thereon forengaging bone within a bone hole. The bone-engaging surface features canhave the same configuration as discussed above with respect to sheath200, or they can have other configurations. As best shown in FIG. 8B, inthis embodiment each sidewall 602, 604 has three columns of teeth spacedlongitudinally along the sidewall between the proximal and distal ends,namely a central column of teeth 608 c, and left and right side columnsof teeth 6081, 608 r. Each tooth is generally rectangular in shape,however a distal facing sidewall 608 d of each tooth can be angledtoward the proximal end 600 p to facilitate insertion into the bonehole, and to prevent proximal movement of the sheath 600 once implantedin the bone hole.

As indicated above, a distal end 600 d of each sidewall 602, 604 caninclude a cross-bar 610 a, 610 b formed thereon. Each cross-bar 610 a,610 b can extend substantially perpendicular to the longitudinal axis ofthe sheath 600 and can have a length that is substantially the same asor more preferably greater than a width of the sidewalls of the sheath600. Such a configuration can allow the cross-bars 610 a, 610 b to beseated within a notch formed in prongs on the sheath inserter tool 500,discussed below. The illustrated cross-bars 610 a, 610 b have asubstantially cylindrical shape with a planar inner surface such thatthe cross-bars will form a complete cylinder when the sidewalls 602, 604are seated adjacent to one another. A tendon or ligament can bepositioned around the cross-bars 610 a, 610 b and can extend along theouter surface of each sidewall 602, 604. In use, when an expander 400(shown in FIG. 1) is inserted into the sheath 600, the sheath insertertool 500 will maintain the cross-bars 610 a, 610 b in a coupledconfiguration and thus the sidewalls 602, 604 will pivot about alongitudinal axis of the cross-bars 610 a, 610 b to move apart andengage bone, as will be discussed in further detail below.

As indicated above, the sheath inserter tool 500 in this embodiment caninclude various features for mating with and interacting with the sheath600. As shown in more detail in FIGS. 9A and 9B, the sheath insertertool 500 generally includes an outer shaft 510, an inner shaft 520configured to extend through the outer shaft 510, and a handle 530 forcoupling to the outer and inner shafts 510, 520. The sheath insertertool 500 can include any of the features described above with respect tothe sheath inserter tool 100. In general, the outer shaft 510 is similarto the above embodiment and includes opposed first and second prongs502, 504 extending distally from a distal end 510 d thereof. A proximalend 510 p of the outer shaft 510 is configured to fixedly mate to thehandle 530, e.g., by a press-fit or other known techniques, such thatthe outer shaft 510 and the handle 530 function as a unit. In thisembodiment, the handle 530 has a generally elongate shape with an outerdiameter that increases at a distal end 530 d and that tapers radiallyoutward toward the proximal end 530 p, however the handle 530 can have avariety of shapes and sizes.

The prongs 502, 504 extending from the distal end 510 d of the outershaft 510 can each have a configuration similar to the prongs describedabove, however in this embodiment each prong 502, 504 includes a notch502 n, 504 n formed in the distal-most end thereof for seating thecross-bars 610 a, 610 b. As shown, each notch 502 n, 504 n can have agenerally circular shape that corresponds to a shape of the cross-bars610 a, 610 b when mated. The length of the prongs 502, 504 areconfigured such that the prongs 502, 504 will maintain the sheath 600 ina position in which a proximal-most end 600 p of the sheath 600 isaligned with a shoulder 512 formed on the distal end 510 d of the outershaft 510. The shoulder 512 is configured to abut against an outersurface of bone when the prongs 502, 504 are positioned within a bonehole to limit insertion of the outer shaft 510 into the bone hole. Theprongs 502, 504 will thus position the sheath 600 at a desired depthwithin the bone hole.

The prongs 502, 504 can include other features similar to thosedescribed above. For example, as shown in more detail in FIG. 9B, eachprong 502, 504 can include first and second bosses (only two bosses 506a, 506 b on prong 502 are shown) formed on an internal surface thereof.As shown, the first boss 506 a is positioned at or near the proximal endof the prong 502 and it can be in the form of a protrusion that isconfigured to extend between the left row of teeth 608L on each sidewall602, 604 of the sheath 600. The second boss 506 b is located distal ofthe first boss 506 a, e.g., around a mid-portion of the prong 502, andit can extend between the right row of teeth 608R on each sidewall 602,604 of the sheath 600. The bosses 506 a, 506 b can function to preventdistal movement of the sheath 600 with respect to the sheath insertertool 500, i.e., to prevent the sheath 600 from falling into the bonehole. While FIG. 9B only illustrates the bosses 506 a, 506 b on thefirst prong 502, a person skilled in the art will appreciate that thesecond prong 504 can include a corresponding set of bosses.

FIG. 9B also illustrates shaped opening 514 at the distal end of theinner lumen in the outer shaft 510 and located at the proximal end ofthe prongs 502, 504. The shaped opening 514 has a shape that conforms toan outer surface of the inner shaft 520 at the distal end so as toreceive the inner shaft 520 therethrough and to maintain the inner shaft520 in longitudinal alignment with the sheath 600 during advancement ofthe inner shaft 520 into the sheath 600. In the illustrated embodiment,the shaped opening 514 is circular, however the opening can have variousconfigurations.

FIG. 9B also illustrates several windows or cut-outs 516 formed in theouter shaft 510 adjacent the distal end for enabling viewing into theinner lumen, and in particular for enabling viewing of the inner shaft520 as well as the expander inserter tool when positioned within theouter shaft 510. A person skilled in the art will appreciate that theouter shaft 510 can have any number of windows or cut-outs formedtherein at various locations, as discussed above with respect to outershaft 102.

As indicated above, the sheath inserter tool 500 also includes an innershaft 520 that is configured to extend through the outer shaft 510.Referring back to FIG. 9A, the inner shaft 520 generally has an elongatecylindrical shape with a proximal end having a handle 522 formed thereonand a distal end having a plug or distal tip 524 configured to extendinto the sheath 600. The handle 522 can have various configurations, butas shown the handle 522 is generally disc-shaped with a planar proximalend surface for receiving a force from a hammer if necessary. When theinner shaft 520 is inserted into the outer shaft 510, the handle 522 onthe inner shaft 520 will abut the proximal end surface of the handle 530coupled to the outer shaft 510, thereby limiting an insertion depth ofthe distal tip 524 on the inner shaft 520 into the sheath 600.

As shown in FIG. 9C, the handle 522 on the inner shaft 520 can includean anti-rotation lock 526 formed thereon and extending distally from adistal-facing surface thereof. The anti-rotation lock 526 can beconfigured to extend into a corresponding slot or bore 532 formed in theproximal end of the handle 530 coupled to the outer shaft 510 to therebyprevent rotation of the inner shaft 520 relative to the outer shaft 510.The anti-rotation lock 526 and bore 532 also facilitate alignment of thedistal tip 524 with the sheath 600. As further shown in FIG. 9C, theanti-rotation lock 526 can include a protrusion or boss 527 formedtherein that is configured to engage a corresponding detent or bore 533extending from the bore 532. The boss 527 and bore 533 create africtional detect between the handle 522 on the inner shaft 520 and thehandle 520 on the outer shaft 510.

The distal tip 524 of the inner shaft 520 is shown in more detail inFIG. 9D, and as shown the distal tip 524 has a protrusion 528, similarto the protrusion 128 discussed above with the previous embodiment. Theillustrated protrusion 528 has a generally oval-shaped cross-sectionsuch that it corresponds to a shape of the inner lumen of the sheath 600when the sidewalls 602, 604 are coupled and the sheath 600 is in theclosed configuration.

As further shown in FIG. 9D, the inner shaft 520 can also include agroove 529 formed in the distal end thereof and extendingcircumferentially around the distal tip 528. The groove 529 can have ashape and size that corresponds to a shape and size of the proximal endof each sidewall 602, 604 of the sheath 600 such that the groove 529 isconfigured to seat the proximal end of each sidewall 602, 604 of thesheath 600. As a result of the groove 529, the outer sidewalls of theinner shaft 520 will extend around the proximal ends of the sidewalls602, 604 of the sheath 600, thereby preventing movement (e.g., opening)of the sheath 600 when the inner shaft 520 is coupled to the sheath 600.The inner shaft 520 will thus maintain the sheath 600 in the closedposition.

FIG. 10 illustrates the sheath 600 and sheath inserter tool 500 fullyassembly, with the distal tip (not shown) of the inner shaft 520 fullyinserted into the sheath 600. As shown, the cross-bars 610 a, 610 b onthe sheath 600 are seated within the notches 502 n, 504 n in the distalends of the prongs 502, 504, and the bosses (only two bosses 506 a, 506are shown) on the prongs 502, 504 extend between the teeth (bosses 506a, 506 b are shown extending between the right teeth 608L) on the sheath600 to prevent the sheath 600 from moving distally relative to theprongs 502, 504. The proximal end of the sheath 600 is aligned with theshoulder 512 on the outer shaft 510, and the proximal end of eachsidewall 602, 604 extends into the groove 529 in the inner shaft 520.The inner shaft 520 will thus maintain the sidewalls 602, 604 in theclosed position during insertion into a bone hole. The groove 529seating the proximal end of each sidewall 602, 604 can also function toapply a distally-directed force on the sheath 600 during insertion intoa bone hole so as to alleviate some of the force applied to thecross-bars 610 a, 610 b. Once the sheath 600 is fully inserted into thebone hole, the inner shaft 520 can be removed from the outer shaft 510and the expander inserter tool 300 can be advanced through the outershaft 510 to drive the expander 400 into the sheath 600 and therebyexpand and anchor the sheath 600, and a tendon positioned there around,within the bone hole. As the sheath 600 is expanded, the bosses willbecome disengaged with the teeth on the sheath sidewalls 602, 604, thusallowing the outer shaft 510 to be subsequently removed.

The systems described herein can be used to implant a sheath or anchorin a bone in various different ways. One exemplary method for implantingan anchor in bone, for example, to perform a biceps tenodesis surgery,is described in U.S. application Ser. No. 14/610,602, filed on Jan. 30,2015 and entitled “Biceps Tenodesis Implants and Delivery Tools,” whichis hereby incorporated by reference in its entirety.

In a biceps tenodesis procedure, a biceps tendon is retrieved in asuitable manner and a size of the tendon is determined to allow asurgeon to select an appropriately sized implant and tools. Further, insome embodiments, the sheath inserter tool 100 or 500 can be used tosize the tendon by using the prongs 108 a, 108 b or 502, 504. Toolshaving different sizes can have differently sized prongs or forks. Afterproperly sizing the tendon, the proper size reamer can be used to ream abore in the bone, e.g., the humerus. However, a person skilled in theart will appreciate that the bone hole can be formed using any suitablebone hole preparation techniques and devices.

The bone hole diameter can be sized to allow the prongs having a tendonpositioned between the prongs thereof and around the sheath to be easilyinserted therein. If sheath 200′ is used, the depth-stop tabs 221 a′,221 b′ on the sheath 200′ can prevent over insertion of the sheath intothe bone hole. In other embodiments, the outer shaft, e.g., outer shaft102 of sheath inserter tool 100, can include laser markings formedtherein for indicating the insertion. In yet another embodiment, theouter shaft, e.g., outer shaft 510 of sheath inserter tool 500, caninclude a shoulder 512 formed thereon having a greater diameter comparedto the bone hole, so that the outer shaft 510 will be prevented fromentering into the bone hole.

After a bone hole in bone is prepared, the sheath coupled to a distalend of the sheath inserter tool can be positioned adjacent to the tendonto be advanced into the bone hole. The inserter tool with the sheathcoupled thereto can be advanced into the bone hole, and the inner shaft,e.g., inner shaft 104 or 520, can be removed leaving the outer shaft,e.g., outer shaft 102 or shaft 510 in place holding the sheath withinthe bone hole. The expander inserter tool, e.g., tool 300, can beadvanced with the expander 400 coupled thereto through the outer shaftand it can be driven into the sheath. A surgeon can hold the handlecoupled to the outer shaft of the sheath inserter tool so that thehandle remains stationary while the expander inserter tool is rotated.The outer shaft of the sheath inserter tool will thus prevent rotationof the sheath during rotation of the expander into the sheath. Theexpander will cause the sheath to expand, with the proximal end expanderradially outward by a distance that is greater than the distal end. Thesheath will engage the bone hole with the tendon therebetween, thusanchoring the tendon within the bone hole. It should be appreciated thatin some embodiments a guidewire and/or a suture can be additionallyused.

A person skilled in the art will appreciate that the biceps tenodesismethods and devices disclosed herein can be used in a variety ofsurgical procedures to prevent trauma or damage to a tendon beingattached to a bone via a bone hole. The present invention also hasapplication in conventional joint repair surgeries.

The devices disclosed herein can be designed to be disposed of after asingle use, or they can be designed to be used multiple times. In eithercase, however, the device can be reconditioned for reuse after at leastone use. Reconditioning can include any combination of the steps ofdisassembly of the device, followed by cleaning or replacement ofparticular pieces, and subsequent reassembly. In particular, the devicecan be disassembled, and any number of the particular pieces or parts ofthe device can be selectively replaced or removed in any combination.Upon cleaning and/or replacement of particular parts, the device can bereassembled for subsequent use either at a reconditioning facility, orby a surgical team immediately prior to a surgical procedure. Thoseskilled in the art will appreciate that reconditioning of a device canutilize a variety of techniques for disassembly, cleaning/replacement,and reassembly. Use of such techniques, and the resulting reconditioneddevice, are all within the scope of the present application.

Preferably, the invention described herein will be processed beforesurgery. First, a new or used instrument is obtained and if necessarycleaned. The instrument can then be sterilized. In one sterilizationtechnique, the instrument is placed in a closed and sealed container,such as a plastic or TYVEK bag. The container and instrument are thenplaced in a field of radiation that can penetrate the container, such asgamma radiation, x-rays, or high-energy electrons. The radiation killsbacteria on the instrument and in the container. The sterilizedinstrument can then be stored in the sterile container. The sealedcontainer keeps the instrument sterile until it is opened in the medicalfacility.

It is preferred that device is sterilized. This can be done by anynumber of ways known to those skilled in the art including beta or gammaradiation, ethylene oxide, steam.

One skilled in the art will appreciate further features and advantagesof the invention based on the above-described embodiments. Accordingly,the invention is not to be limited by what has been particularly shownand described, except as indicated by the appended claims. Allpublications and references cited herein are expressly incorporatedherein by reference in their entirety.

What is claimed is:
 1. A bone anchor inserter tool, comprising: anelongate shaft having proximal and distal ends and an inner lumenextending therethrough, the distal end having first and second prongsextending distally therefrom and positioned on opposite sides of theshaft, each prong having a first pair of bosses positioned adjacent aproximal end of each prong and a second pair of bosses positionedadjacent a mid-portion of each prong, wherein each boss of the secondpair of bosses is a protrusion extending outwardly from a side of eachprong, and each boss of the second pair of bosses extends outwardly fromopposite sides of each prong.
 2. The bone anchor inserter tool of claim1, wherein the first pair of bosses extend radially outward from eachprong by a first distance and the second pair of bosses extend radiallyoutward from each prong by a second distance that is less than the firstdistance.
 3. The bone anchor inserter tool of claim 1, wherein theelongate shaft includes at least one viewing window formed in a sidewallthereof at a location proximal to the first and second prongs to allowviewing into the inner lumen of the elongate shaft.
 4. A tendonanchoring system, comprising: an anchor assembly having a sheath withfirst and second sidewalls that are coupled at a distal end by a hingepin having a longitudinal axis such that the first and second sidewallsare configured to pivot about the hinge pin relative to one another,each sidewall having an anti-rotation boss formed thereon and extendingfrom the sidewall in a direction parallel to the longitudinal axis ofthe hinge pin; an inserter tool including an elongate shaft having aninner lumen extending therethrough between proximal and distal ends, thedistal end having first and second prongs extending distally therefromfrom opposite sides thereof and configured to extend along opposed sidesof the first and second sidewalls of the sheath such that the first andsecond prongs are engaged between the anti-rotation boss on eachsidewall to prevent rotation of the sheath relative to the first andsecond prongs.
 5. The system of claim 4, wherein each sidewall furtherincludes a retention boss positioned proximal of the anti-rotation bossand configured to engage an expander positioned between the first andsecond sidewalls of the anchor assembly.
 6. The system of claim 5,wherein the first and second prongs each include a proximal bosspositioned proximal of the retention boss on the first and secondsidewalls, and a distal boss positioned proximal of the anti-rotationboss on the first and second sidewalls and distal of the retention bosson the first and second sidewalls.
 7. The system of claim 4, furthercomprising an expander having a generally elongate cylindricalconfiguration and configured to be received between the first and secondsidewalls of the sheath to cause the first and second sidewalls to pivotabout the hinge pin and move laterally away from one another.
 8. Thesystem of claim 4, wherein a proximal end of at least one of the firstand second sidewalls has a tab extending radially outward therefrom, thetab being received within a slot in the distal end of the elongate shaftof the inserter tool to facilitate engagement between the sheath and theinserter tool.